Answered step by step
Verified Expert Solution
Question
1 Approved Answer
Can simeone please answer these for me. I'll rate good. Scenario: Imagine that you are the quality manager or its equivalent in an organization in
Can simeone please answer these for me. I'll rate good.
Scenario: Imagine that you are the quality manager or its equivalent in an organization in a designated industry. You have suggested that top management introduces a Quality Management System (QMS) based on the ISO 9001:2015 standard into the organization and opt for certification later (a) Prepare a briefing note capturing responses to Questions 1 to 15 for top management to make a decision (b) For each question below, responses must be specific to an industry setting industry Standards SOPs, Job Descriptions Quality Policyta Group Focus Area 1 Hotel (Tourism industry) 2 University Education industry 3 Airline (Aviation industry Botting Company (Consumer Goods Industry 5 Restaurant (Consumer Services Tourism industry 6. Car Manufacturing (Manufacturing Technology industry 7. Hospital Health Industry 8 Bank Financial Industry 9 Online B2C Sales E-Commerce Industry 10. Gas Station Energy Industry) TV Station Entertainment industry) 12 Beverage (Consumer Goods Industry) Insurance Financial industry Questions to be captured in briefing notes: 1. What are the Quality Management Principles on which the ISO 9001:2015 is hinged? From the ISO Standard, provide clear examples of typical actions to improve the organization's performance when applying each principle 2. The ISO 9001:2015 uses the process approach provide four (4) glaring benefits of applying the process approach 3. The PDCA is the cornerstone on which the ISO 9001:2015 is built what set of actions happen under each phase and which clauses are relevant under each phase of the cycle? 4 When the 150 9001:2015 talks about Risk-based thinking, what is the rationale and which clauses provide actions for risk-based thinking under the standard? 5. How does the organization establish a QMS under the ISO 9001:2015 standard? 6 What is the responsibility of leadership under the 150 9001:2015 Clause 5.1 7. When planning how to achieve its quality objectives, the organization should take into consideration five (5) major factors, explain these factors 8. What are the ways that an organization can employ to deal with non-conforming outputs? 9. When a non-conformity occurs, what are the steps the organization should take to handle the non-conformity? 10. When communicating to its internal and external customers, the organizacion must consider five (5) key factors, explain these factors? 11. Explain to your management why it is relevant to have the following Documents and show them what the team has produced TLA Scope of the Quality Management System ISO 9001:2015 Clause 4.3 11.B Quality Policy (ISO 9001:2015 Clause 52) TLD Standard Operating Procedures (SOP 1LD1 Documentation Policy (Show the documentation pyramid for your organization) 11D2 Organization Charts 11D.2 Process Map (Flowchart) Internal Audit Questions 1A. During an internal audit, the Auditor is shown the audit report of previous internal audit, which include a non-conformity report stating that three (3) staff in purchase department had not been trained in the use of approved supplier list. The correction action taken was to verify all the pre-approved supplier list and bring them into conformance to the so mity was closed thereafter. The Purchase Department Audit further instination and action Internal Audit Questions 1A. During an internal audit, the Auditor is shown the audit report of previous internal audit, which include a non-conformity report stating that three (3) staff in purchase department had not been trained in the use of approved supplier list. The correction action taken was to verify all the pre-approved supplier list and bring them into conformance to the set criteria. The audit report non-conformity was closed thereafter. The Purchase Department Auditee tells you that no further investigation and actions were taken afterwards. You have checked the associated records, and it confirms the Auditee's narration. If you think there is evidence of non-conformity, complete the Non- conformity Report, stating the relevance of each action 18. In an internal audit, the auditee/process owner at the Registry in the University of XYZ says that the University has excluded Clause 853 of the ISO 9001:2015 Standard (which deals with property belonging to customers or external providers) in its Quality Page 2 of 5 Manual and therefore argues that the audit cannot cover this Clause. You have checked the scope set out in the Quality Manual, and this assertion is confirmed. 181 Can the University claim exclusion under this Clause? YES or NO and explain why. 18.2 If this anomaly is corrected, what obligations will be imposed on the University under Clause 8.53 of the Standard? 1.C. In an internal audit, the Training Department in a bank could not show procedures that identified the training needs for all personnel The Training Department Manager explained that the bank had been operating for 20 years and the work had become routine. He claimed there was no need to establish such a troublesome procedure. If the firm has built its Quality Management System (QMS) on the ISO 9001:2015 Standard, what is the non-conformity here and what is recommended under the standard? SECTION B You have managed to convince top management that adopting a QMS based on the ISO 9001:2015 will turn around the company's fortunes and allow it to leapfrog the competition. They have approved your proposal, and since that time, your organization has used the QMS for 2 years and is now attempting to get certification for 150 9001:2015; hence, management has directed that a first-party audit should be conducted to establish any gaps within the Quality Management System (QMS) being implemented at the organization in preparation for the second-party and third-party audit, which will assess the organization for certification. As the process owner, you are to assess the extent of compliance of the organization's QMS and effect corrective measures to streamline the QMS to acceptable standards for certification. The table below provides key findings after the audit, you are to fill in the missing details, le i) Clause Reference from the ISO Standard 9001:2015, li) Ratings, here you are establishing conformance or non-conformance and its severity, and lii) the Audit Evidence available or missing Rating Keys: Minor Non-conformance Major Non-conformance Critical Non-conformance Page 3 of 5 Audit Finding No. 00 02 03 04 388 07 08 09 10 TI 15 % 15 36 17 18 20 Audit Findings The organization does NOT have a documented quality policy? Customer requirements are NOT determined at every stage of the firm's operations The organization has a quality manual, but it has NOT been communicated to the employees The organization has NOT established, documented implemented and maintained a QMS The organization does NOT monitor, measure and analyze QMS processes? The organization has NOT established mechanisms to maintain control over outsourced processes? The organization has put in place actions necessary to achieve planned results and continual improvement of processes needed for the QMST Changes and the current revision status of documents are NOT identified? When document changes are made the relevant parties are NOT informed in product design and development planning, the organization has NOT established the responsibilities and authorities involved in the design and development The organization does NOT conduct a review before committing to supply products and services to a customer The organization has NOT determined the boundaries and applicability of the quality management system to establish its scope The organization has established the interested parties that are relevant to the quality management system, but the requirements of these interested parties are NOT known in deciding the QMS and its processes, the organization has NOT determined the sequence and interaction of these processes Documented information is NOT adequately protected jeg from loss of confidentiality, improper use, or loss of integrity) Quality policy and quality objectives are established for the quality management system, but are NOT compatible with the context and strategic direction of the organization Responsibilities and authorities for relevant roles are NOT assigned communicated and understood within the organization The organization has NOT put in place actions to address een ser but are NOT cont with the quality policy When the organization determines the need for changes to the quality management system, it does NOT consider the purpose of the changes and their potential Clause Reference Page 4 of 5 PS5 NO Ratings YES ABC Audit Evidence Scenario: Imagine that you are the quality manager or its equivalent in an organization in a designated industry. You have suggested that top management introduces a Quality Management System (QMS) based on the ISO 9001:2015 standard into the organization and opt for certification later (a) Prepare a briefing note capturing responses to Questions 1 to 15 for top management to make a decision (b) For each question below, responses must be specific to an industry setting industry Standards SOPs, Job Descriptions Quality Policyta Group Focus Area 1 Hotel (Tourism industry) 2 University Education industry 3 Airline (Aviation industry Botting Company (Consumer Goods Industry 5 Restaurant (Consumer Services Tourism industry 6. Car Manufacturing (Manufacturing Technology industry 7. Hospital Health Industry 8 Bank Financial Industry 9 Online B2C Sales E-Commerce Industry 10. Gas Station Energy Industry) TV Station Entertainment industry) 12 Beverage (Consumer Goods Industry) Insurance Financial industry Questions to be captured in briefing notes: 1. What are the Quality Management Principles on which the ISO 9001:2015 is hinged? From the ISO Standard, provide clear examples of typical actions to improve the organization's performance when applying each principle 2. The ISO 9001:2015 uses the process approach provide four (4) glaring benefits of applying the process approach 3. The PDCA is the cornerstone on which the ISO 9001:2015 is built what set of actions happen under each phase and which clauses are relevant under each phase of the cycle? 4 When the 150 9001:2015 talks about Risk-based thinking, what is the rationale and which clauses provide actions for risk-based thinking under the standard? 5. How does the organization establish a QMS under the ISO 9001:2015 standard? 6 What is the responsibility of leadership under the 150 9001:2015 Clause 5.1 7. When planning how to achieve its quality objectives, the organization should take into consideration five (5) major factors, explain these factors 8. What are the ways that an organization can employ to deal with non-conforming outputs? 9. When a non-conformity occurs, what are the steps the organization should take to handle the non-conformity? 10. When communicating to its internal and external customers, the organizacion must consider five (5) key factors, explain these factors? 11. Explain to your management why it is relevant to have the following Documents and show them what the team has produced TLA Scope of the Quality Management System ISO 9001:2015 Clause 4.3 11.B Quality Policy (ISO 9001:2015 Clause 52) TLD Standard Operating Procedures (SOP 1LD1 Documentation Policy (Show the documentation pyramid for your organization) 11D2 Organization Charts 11D.2 Process Map (Flowchart) Internal Audit Questions 1A. During an internal audit, the Auditor is shown the audit report of previous internal audit, which include a non-conformity report stating that three (3) staff in purchase department had not been trained in the use of approved supplier list. The correction action taken was to verify all the pre-approved supplier list and bring them into conformance to the so mity was closed thereafter. The Purchase Department Audit further instination and action Internal Audit Questions 1A. During an internal audit, the Auditor is shown the audit report of previous internal audit, which include a non-conformity report stating that three (3) staff in purchase department had not been trained in the use of approved supplier list. The correction action taken was to verify all the pre-approved supplier list and bring them into conformance to the set criteria. The audit report non-conformity was closed thereafter. The Purchase Department Auditee tells you that no further investigation and actions were taken afterwards. You have checked the associated records, and it confirms the Auditee's narration. If you think there is evidence of non-conformity, complete the Non- conformity Report, stating the relevance of each action 18. In an internal audit, the auditee/process owner at the Registry in the University of XYZ says that the University has excluded Clause 853 of the ISO 9001:2015 Standard (which deals with property belonging to customers or external providers) in its Quality Page 2 of 5 Manual and therefore argues that the audit cannot cover this Clause. You have checked the scope set out in the Quality Manual, and this assertion is confirmed. 181 Can the University claim exclusion under this Clause? YES or NO and explain why. 18.2 If this anomaly is corrected, what obligations will be imposed on the University under Clause 8.53 of the Standard? 1.C. In an internal audit, the Training Department in a bank could not show procedures that identified the training needs for all personnel The Training Department Manager explained that the bank had been operating for 20 years and the work had become routine. He claimed there was no need to establish such a troublesome procedure. If the firm has built its Quality Management System (QMS) on the ISO 9001:2015 Standard, what is the non-conformity here and what is recommended under the standard? SECTION B You have managed to convince top management that adopting a QMS based on the ISO 9001:2015 will turn around the company's fortunes and allow it to leapfrog the competition. They have approved your proposal, and since that time, your organization has used the QMS for 2 years and is now attempting to get certification for 150 9001:2015; hence, management has directed that a first-party audit should be conducted to establish any gaps within the Quality Management System (QMS) being implemented at the organization in preparation for the second-party and third-party audit, which will assess the organization for certification. As the process owner, you are to assess the extent of compliance of the organization's QMS and effect corrective measures to streamline the QMS to acceptable standards for certification. The table below provides key findings after the audit, you are to fill in the missing details, le i) Clause Reference from the ISO Standard 9001:2015, li) Ratings, here you are establishing conformance or non-conformance and its severity, and lii) the Audit Evidence available or missing Rating Keys: Minor Non-conformance Major Non-conformance Critical Non-conformance Page 3 of 5 Audit Finding No. 00 02 03 04 388 07 08 09 10 TI 15 % 15 36 17 18 20 Audit Findings The organization does NOT have a documented quality policy? Customer requirements are NOT determined at every stage of the firm's operations The organization has a quality manual, but it has NOT been communicated to the employees The organization has NOT established, documented implemented and maintained a QMS The organization does NOT monitor, measure and analyze QMS processes? The organization has NOT established mechanisms to maintain control over outsourced processes? The organization has put in place actions necessary to achieve planned results and continual improvement of processes needed for the QMST Changes and the current revision status of documents are NOT identified? When document changes are made the relevant parties are NOT informed in product design and development planning, the organization has NOT established the responsibilities and authorities involved in the design and development The organization does NOT conduct a review before committing to supply products and services to a customer The organization has NOT determined the boundaries and applicability of the quality management system to establish its scope The organization has established the interested parties that are relevant to the quality management system, but the requirements of these interested parties are NOT known in deciding the QMS and its processes, the organization has NOT determined the sequence and interaction of these processes Documented information is NOT adequately protected jeg from loss of confidentiality, improper use, or loss of integrity) Quality policy and quality objectives are established for the quality management system, but are NOT compatible with the context and strategic direction of the organization Responsibilities and authorities for relevant roles are NOT assigned communicated and understood within the organization The organization has NOT put in place actions to address een ser but are NOT cont with the quality policy When the organization determines the need for changes to the quality management system, it does NOT consider the purpose of the changes and their potential Clause Reference Page 4 of 5 PS5 NO Ratings YES ABC Audit Evidence Step by Step Solution
There are 3 Steps involved in it
Step: 1
Get Instant Access to Expert-Tailored Solutions
See step-by-step solutions with expert insights and AI powered tools for academic success
Step: 2
Step: 3
Ace Your Homework with AI
Get the answers you need in no time with our AI-driven, step-by-step assistance
Get Started